A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

NCT ID: NCT02915809

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Detailed Description

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Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GC3110B Vaccine Group

Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).

Group Type EXPERIMENTAL

GC3110B vaccine

Intervention Type BIOLOGICAL

0.5mL, Intramuscular

GCFLU Quadrivalent Inj.

Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).

Group Type ACTIVE_COMPARATOR

GCFLU Quadrivalent Inj. vaccine

Intervention Type BIOLOGICAL

0.5mL, Intramuscular

Interventions

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GC3110B vaccine

0.5mL, Intramuscular

Intervention Type BIOLOGICAL

GCFLU Quadrivalent Inj. vaccine

0.5mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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GC3110B GCFLU Quadrivalent Inj.

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 18 to 60 years
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria

* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barré syndrome
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GC3110B_P3

Identifier Type: -

Identifier Source: org_study_id

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